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MTBVAC

MTBVAC is a live attenuated tuberculosis vaccine that stimulates immune responses against Mycobacterium tuberculosis to prevent active TB disease.

MTBVAC is a live attenuated tuberculosis vaccine that stimulates immune responses against Mycobacterium tuberculosis to prevent active TB disease. Used for Tuberculosis prevention in adolescents and adults (Phase 3).

At a glance

Mechanism of action

MTBVAC is a genetically modified live vaccine derived from M. tuberculosis with deletions in two genes (RD1 and panCD) that reduce virulence while preserving immunogenicity. It is designed to induce both cellular and humoral immune responses to protect against TB infection and disease progression. The vaccine aims to provide superior protection compared to the standard BCG vaccine, particularly in preventing pulmonary TB in adolescents and adults.

Approved indications

• Tuberculosis prevention in adolescents and adults (Phase 3)

Common side effects

• Local injection site reactions (erythema, induration, pain)
• Fever
• Fatigue
• Headache

Key clinical trials

• Evaluating the Safety and Immunogenicity of MTBVAC (PHASE2)
• A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region. (PHASE2)
• Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024) (PHASE2)
• Tuberculosis Vaccine in Healthy Indian Adults (PHASE1)
• Dose-Defining Safety and Immunogenicity Study of MTBVAC in South African Neonates (PHASE2)
• Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa (PHASE3)
• MTBVAC Study in Adults With and Without Latent Tuberculosis Infection in South Africa (PHASE1, PHASE2)
• Epidemiological Study In Tuberculosis-Endemic Urban Area in Senegal

Primary sources

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